Obinutuzumab

Generic Name: Obinutuzumab

Brand Names: Gazyva, Gazyvaro

Drug Type: Biotech

CAS Number: 949142-50-1

Unique Ingredient Identifier: O43472U9X8

Background: Obinutuzumab is a humanized monoclonal antibody used as a combination treatment with chlorambucil to treat patients with untreated chronic lymphocytic leukemia. It was approved by the FDA in November 2013 and is marketed under the brand name Gazyva. There is a black box warning of fatal Hepatitis B Virus (HBV) reactivation and fatal Progressive Multifocal Leukoencephalopathy (PML).

Indication: Obinutuzumab is used as a combination treatment with chlorambucil to treat patients with untreated chronic lymphocytic leukemia.

Associated Conditions: Refractory Follicular Lymphoma, Previously untreated Chronic lymphocytic leukemia

Clinical Trials

A Study to Evaluate the Safety and Anti-cancer Activity of Loncastuximab Tesirine in Combination With Other Anti-cancer Agents in Participants With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (LOTIS-7)

Phase 1

Recruiting

Conditions: B-Cell Non-Hodgkin Lymphoma
Relapsed B-Cell Non-Hodgkin Lymphoma
Refractory B-Cell Non-Hodgkin Lymphoma

Interventions: Drug: Loncastuximab Tesirine
Drug: Polatuzumab Vedotin
Drug: Glofitamab
Drug: Mosunetuzumab
Drug: Obinutuzumab

First Posted Date: 2021-07-21

Last Posted Date: 2025-05-22

Lead Sponsor: ADC Therapeutics S.A.

Target Recruit Count: 200

Registration Number: NCT04970901

Locations: 🇺🇸
Columbia University Irving Medical Center, New York, New York, United States
🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
🇨🇿
Fakultni Nemocnice Brno, Brno, South Moravian, Czechia

and more 38 locations

A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With Systemic Lupus Erythematosus

Phase 3

Active, not recruiting

Conditions: Systemic Lupus Erythematosus

Interventions: Drug: Placebo
Drug: Obinutuzumab
Drug: Acetaminophen/Paracetamol
Drug: Diphenhydramine hydrochloride
Drug: Methylprednisolone

First Posted Date: 2021-07-15

Last Posted Date: 2025-04-13

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 300

Registration Number: NCT04963296

Locations: 🇺🇸
Pinnacle Research Group, Anniston, Alabama, United States
🇺🇸
Unity Health - White County Medical Center- Rheumatology, Searcy, Arkansas, United States
🇺🇸
Providence Medical Foundation, Fullerton, California, United States

and more 67 locations

Frontline Treatment of Follicular Lymphoma with AtezolizUmab and Obinutuzumab with and Without RadiOtherapy

Phase 2

Active, not recruiting

Conditions: Follicular Lymphoma

Interventions: Drug: Obinutuzumab 25 MG/1 ML Intravenous Solution
Drug: Atezolizumab 1200 MG/40mL Intravenous Solution
Radiation: 4 Gy in 2 fractions

First Posted Date: 2021-07-14

Last Posted Date: 2025-03-21

Lead Sponsor: Olivia Newton-John Cancer Research Institute

Target Recruit Count: 15

Registration Number: NCT04962126

Locations: 🇦🇺
Ballarat Health Service, Ballarat, Victoria, Australia
🇦🇺
Eastern Health, Box Hill, Victoria, Australia
🇦🇺
Austin Health, Heidelberg, Victoria, Australia

Adjustment of Chemotherapy Duration in Follicular Lymphoma According to Minimal Residual Disease Status

Phase 2

Recruiting

Conditions: Follicular Lymphoma

Interventions: Drug: Bendamustin
Drug: Obinutuzumab

First Posted Date: 2021-06-22

Last Posted Date: 2021-06-22

Lead Sponsor: Meir Medical Center

Target Recruit Count: 40

Registration Number: NCT04934930

Locations: 🇮🇱
Meir medical center, Kfar Saba, Israel

Obinutuzumab Versus Rituximab for Acute Lymphoblastic Leukemia/PALG ALL7 "OVERALL"

Phase 2

Recruiting

Conditions: CD20-positive Acute Lymphoblastic Leukemia

Interventions: Drug: Rituximab
Drug: Obinutuzumab

First Posted Date: 2021-06-10

Last Posted Date: 2025-04-24

Lead Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology

Target Recruit Count: 124

Registration Number: NCT04920968

Locations: 🇵🇱
Oddział Hematologii i Chorób Wewnętrznych z Pododdziałem Dziennym Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Sp. z o.o., Kraków, Poland
🇵🇱
Oddział Hematologii i Transplantacji Szpiku Centrum Onkologii Ziemi Lubelskiej im. Św. Jana z Dukli w Lublinie, Lublin, Poland
🇵🇱
Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi, Łódź, Poland

and more 16 locations

Study to Assess Change in Disease Activity and Adverse Events of Oral Venetoclax With Intravenous (IV) Obinutuzumab in Adult Participants With Recurring Chronic Lymphocytic Leukemia (CLL)

Phase 2

Recruiting

Conditions: Chronic Lymphocytic Leukemia (CLL)

Interventions: Drug: Venetoclax
Drug: Obinutuzumab

First Posted Date: 2021-05-20

Last Posted Date: 2025-04-25

Lead Sponsor: AbbVie

Target Recruit Count: 75

Registration Number: NCT04895436

Locations: 🇧🇬
UMHAT Sveti Georgi EAD /ID# 272321, Plovdiv, Bulgaria
🇦🇹
Hanusch Krankenhaus /ID# 230010, Wien, Austria
🇩🇪
OncoResearch Lerchenfeld GmbH /ID# 230191, Hamburg, Germany

and more 51 locations

CAR-T Followed by Bispecific Antibodies

Phase 2

Recruiting

Conditions: Large B-cell Lymphoma
DLBCL - Diffuse Large B Cell Lymphoma

Interventions: Drug: mosunetuzumab
Drug: glofitamab
Drug: obinutuzumab

First Posted Date: 2021-05-17

Last Posted Date: 2025-02-12

Lead Sponsor: Abramson Cancer Center at Penn Medicine

Target Recruit Count: 42

Registration Number: NCT04889716

Locations: 🇺🇸
University of Nebraska Medical Center, Omaha, Nebraska, United States
🇺🇸
Abramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, United States

Acalabrutinib and Obinutuzumab for the Treatment of Previously Untreated Follicular Lymphoma or Other Indolent Non-Hodgkin Lymphomas

Phase 2

Recruiting

Conditions: Grade 2 Follicular Lymphoma
Marginal Zone Lymphoma
Grade 1 Follicular Lymphoma
Grade 3a Follicular Lymphoma
Indolent Non-Hodgkin Lymphoma
Lymphoplasmacytic Lymphoma
Lymphoproliferative Disorder
Mantle Cell Lymphoma

Interventions: Drug: Acalabrutinib
Biological: Obinutuzumab
Other: Quality-of-Life Assessment
Other: Questionnaire Administration

First Posted Date: 2021-05-12

Last Posted Date: 2025-03-27

Lead Sponsor: Emory University

Target Recruit Count: 49

Registration Number: NCT04883437

Locations: 🇺🇸
Emory University Hospital/Winship Cancer Institute, Atlanta, Georgia, United States

NAP in Combination With Docetaxel Following Obinutuzumab Pretreatment in Subjects With Checkpoint Inhibitor Pretreated Advanced or Metastatic NSCLC

Phase 2

Completed

Conditions: Non-small Cell Lung Cancer

Interventions: Drug: NAP (Naptumomab estafenatox)
Drug: Docetaxel
Drug: Obinutuzumab

First Posted Date: 2021-05-11

Last Posted Date: 2025-03-03

Lead Sponsor: NeoTX Therapeutics Ltd.

Target Recruit Count: 38

Registration Number: NCT04880863

Locations: 🇺🇸
NeoTX - 10312, El Paso, Texas, United States
🇺🇸
NeoTX - 10310, Tyler, Texas, United States
🇺🇸
NeoTX - 10308, Austin, Texas, United States

and more 8 locations

Avo In R/R And Previously Untreated MCL

Phase 1

Recruiting

Conditions: Mantle Cell Lymphoma
Refractory Lymphoma

Interventions: Drug: Acalabrutinib
Drug: Venetoclax
Drug: Obinutuzumab

First Posted Date: 2021-04-22

Last Posted Date: 2025-01-29

Lead Sponsor: Austin I Kim

Target Recruit Count: 53

Registration Number: NCT04855695

Locations: 🇺🇸
University of Chicago Medical Center, Chicago, Illinois, United States
🇺🇸
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States

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